GlioblastomaNCT03460782
An Expanded Access Program of Ipilimumab for Patients With Glioblastomas and Gliomas
A study testing Ipilimumab in people with Glioblastoma and Glioma of Brain, run by Center Trials & Treatment at 11 sites in 8 countries.
Trial summary
IPILIMUMAB Extended Access Program for patients who received chemotherapy and / or radiation therapy before the protocol, before or after the operation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Glioblastoma, Glioma of Brain
- What is being tested?
- Ipilimumab
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- 11 sitesin 8 countries
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
Who may be able to join
- Glioblastoma.
- Glioma Brain.
- Male or female subjects aged ≥18 years.
- Histopathological evidence of glioblastoma or glioma.
- Patients still alive must provide informed consent if required by local regulations
- Maximal tumor diameter (including residual tumor and resection cavity if subjects had tumor resection rather than only stereotactic biopsy) up to 7cm or less.
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- Karnofsky performance status (Appendix 2) of ≥60.
- Availability of a paraffin-embedded or frozen tumor-tissue block with a minimum of 0.5 cm2 and 5 unstained slides from the glioblastoma or glioma tissue specimen.
- Not earlier than 35 days after surgery.
- An interval of at least 2 week for stereotactic biopsy from the start of study treatment.
- A contrast-enhanced MRI must be obtained within 7 days of the first dose of study treatment.
- Adequate hematologic, hepatic, and renal function defined by test
- Women must have a negative serum or urine pregnancy test before 24 hours of initiation of study drug.
- Any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes. In addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU/mL to be defined as post-menopausal.
- Women receiving ipilimumab will be instructed to adhere to contraception for a period of 35 weeks after the last dose of program.
- Men receiving ipilimumab and who are sexually active will be instructed to adhere to contraception for a period of 39 weeks after the last dose of program.
- Contraception is not required for men with documented vasectomy.
- Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation.
- Women must not be breastfeeding.
- Willing to and capable of providing written informed consent prior to any program related procedures.
- Ability and willingness to comply scheduled visits, treatment plans, laboratory tests, and other program-related procedures.
Who cannot join
- Prior systemic treatment anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways.
- Planned participation in another study intended for therapy of glioma or glioblastoma.
- Primary brainstem or spinal cord tumor.
- Diffuse leptomeningeal gliomatosis.
- Сonfirmed mutation of the IDH1/2 genes.
- Stem or dendritic cell therapy 60 days before the program or 45 days after the last infusion of ipilimumab.
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- Systemic treatment with either immunosuppressive doses of corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 21 days of study drug administration.
- Patients on a standard high-dose steroid taper after craniotomy or stereotactic biopsy may have received a higher dose of corticosteroids within 21 days of registration, however must be at a dose < 5 mg daily prednisone or bioequivalent per day within 7 days prior to initiation of study drug.
- Patients requiring adrenal replacement with corticosteroids are eligible if the steroids are at doses ≤ 10 mg prednisone or bioequivalent per day in the absence of active autoimmune disease.
- Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication) are allowed.
- Active autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent.
- Prior organ transplantation, including allogeneic stem cell transplantation.
- Known history of, or any evidence of active, non-infectious pneumonitis within the last 5 years.
- Known severe (NCI-CTCAE v4.03 Grade 3 or 4) infusion-related allergy or acute hypersensitivity reaction attributed to any monoclonal antibody, any history of anaphylaxis, or uncontrolled asthma (that is, 3 or more features of partially controlled asthma).
- Unable tolerate an MRI, or have a contraindication to MRI.
- Active infection requiring systemic therapy.
- Positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome.
- Positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus (HCV antibody) indicating acute or chronic infection.
- Vaccination within 5 weeks of the first dose of study drug and while on trials is prohibited except for administration of inactivated vaccines.
- ATTENTION: Seasonal influenza vaccines for injection are live attenuated vaccines, and are not allowed.
- Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure (≥ NY Heart Association - CC II), or serious cardiac arrhythmia requiring medication.
- All other unstable, severe, or chronic medical or psychiatric conditions including colitis, inflammatory bowel disease, pneumonitis, pulmonary fibrosis, recent (within the past year) or active suicidal idea in behavior, or laboratory abnormalities that may increase the risk associated with program or judgment of the investigator, would make the patient participation impossible.
Trial locations and contacts
11 sites in 8 countries.
11 sites in 8 countries
Russia3 sites
Regional Oncology Hospital
Irkutsk, 664035
Rostov Cancer Research Institute
Rostov-on-Don, 344037
Primorsky Regional Oncology Center
Vladivostok, 690069
Switzerland2 sites
Inselspital Bern; Medizinische Onkologie
Bern, 3010
Stadtspital Triemli; Frauenklinik
Zurich, 8063
Albania1 site
University "Mother Theresa" Hospital Center; Oncology Department
Tirana, 1000
Bosnia and Herzegovina1 site
University Clinical Center of the Republic of Srpska
Banja Luka, 78000
Croatia1 site
Clinical Hospital Osijek; Dept For Oncology & Radiotherapy
Osijek, 31000
Romania1 site
Institut of Oncology Al. Trestioreanu Bucharest; Oncology
Bucharest, 022338
Serbia1 site
Clinical Hospital Center Bezanijska kosa; Clinic for Oncology
Belgrade, 11 000
About this study
IPILIMUMAB Extended Access Program for patients who received chemotherapy and / or radiation therapy before the protocol, before or after the operation.
Read the detailed description
It is not yet known which protocols are a better treatment for glioblastoma or glioma.
The ipilimumab extended-access program for patients who received previous chemotherapy and / or radiation therapy by protocol, before ((for non-operable cases) or after the operation.
Monoclonal antibodies of CTLA-4, such as ipilimumab, may block tumor growth in different ways by targeting certain cells and activating the patient's immune system to fight the disease.
- Conditions
- Glioblastoma, Glioma of Brain
- Being tested
- Ipilimumab
- Keywords
- Ipilimumab, Glioblastoma, Glioma
- Medical subject headings
- Glioblastoma, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IpilimumabBiological
Also called MDX-010
Each patient receives Ipilimumab in regimen and dose according to the official manufacturer's instructions (IV 1 mg / kg every 6 weeks for maximum of 4 doses).
Participation of the patient in the program must necessarily be agreed with the current treatment and contain a written agreement with the attending physician.
This program is not covered by health insurance. For patients in the postoperative period to provide a mandatory conclusion of histology and molecular-genetic for the identified mutations and the type of tumor.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Center Trials & Treatment
- Sponsor type
- University, hospital or other
- Collaborators
- BioGene Pharmaceutical Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03460782
- Sponsor's protocol ID
- PST-9-IP
- Status last verified
- Nov 2019
- First submitted
- 5 Mar 2018
- Last updated
- 8 Nov 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Expanded Access Program of Ipilimumab for Patients With Glioblastomas and Gliomas
- ClinicalTrials.gov ID
- NCT03460782
- Acronym / sponsor ID
- PST-9-IP
- Conditions
- Glioblastoma, Glioma of Brain
- Keywords
- Ipilimumab, Glioblastoma, Glioma
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Center Trials & TreatmentUniversity, hospital or other
- Collaborators
- BioGene Pharmaceutical Ltd.
- First posted
- 9 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
IPILIMUMAB Extended Access Program for patients who received chemotherapy and / or radiation therapy before the protocol, before or after the operation.
Detailed description
It is not yet known which protocols are a better treatment for glioblastoma or glioma.
The ipilimumab extended-access program for patients who received previous chemotherapy and / or radiation therapy by protocol, before ((for non-operable cases) or after the operation.
Monoclonal antibodies of CTLA-4, such as ipilimumab, may block tumor growth in different ways by targeting certain cells and activating the patient's immune system to fight the disease.
Study design
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Glioblastoma.
- Glioma Brain.
- Male or female subjects aged ≥18 years.
- Histopathological evidence of glioblastoma or glioma.
- Patients still alive must provide informed consent if required by local regulations
Key exclusion criteria (22 listed)
- Prior systemic treatment anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways.
- Planned participation in another study intended for therapy of glioma or glioblastoma.
- Primary brainstem or spinal cord tumor.
- Diffuse leptomeningeal gliomatosis.
- Сonfirmed mutation of the IDH1/2 genes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IpilimumabAlso: MDX-010Each patient receives Ipilimumab in regimen and dose according to the official manufacturer's instructions (IV 1 mg / kg every 6 weeks for maximum of 4 doses). Participation of the patient in the program must necessarily be agreed with the current treatment and contain a written agreement with the attending physician. This program is not covered by health insurance. For patients in the postoperative period to provide a mandatory conclusion of histology and molecular-genetic for the identified mutations and the type of tumor. | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ipilimumab in people with Glioblastoma and Glioma of Brain, run by Center Trials & Treatment at 11 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Russia, Switzerland, Albania, Bosnia and Herzegovina, Bulgaria and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2019.